USE OF BIOSIMILARS IN MEDICINE

Abstract

Biosimilars are worldwide approved biologic products (originator), complex and large molecules that are highly similar to the reference drug according to structure, function, clinical and quality characteristics, representing no clinically noteworthy differences in safety, purity, or potency and immunogenicity in comparison to biologic drugs. While high cost of healthcare system limits the access of patient population to treatment, biosimilars considered as important healthcare treatment options, reducing the costs for patients and for insurance companies. Development and regulatory approval of biosimilars need specific guide-line developed by The European Medicines Agency, United States Food and Drug Administration and World Health Organization. (Ahmed, 2016; Pittman, 2019). At present there are some approved biosimilars in oncology and treatment of autoimmune diseases. Biologics (monoclonal antibodies [mAbs] and hematopoietic agents) are recommended in oncology guidelines and supportive oncology care (reducing common adverse effects following chemotherapy), enhancing clinical, health-related quality of life. Biologics such as Epoetin alfa, darbepoetin, Filgrastim and its analog and pegfilgrastim that are produced using recombinant DNA technology are included as agents that provide restoring hematological response. Also, it is worthy of note that biosimilars are not only widely used in cancer treatment and supportive care in Europe and USA, but in the Middle east and Asia because of cost saving and the same safety and efficacy. Since regulatory framework for biosimilars introduced in Europe earlier than USA, higher number of these agents are approved by European countries according to nonclinical and pharmaceutical evidences. (Patel, 2018). It is well-known that biologics (biosimilars) have considerable effect on the clinical management of inflammatory conditions like rheumatoid arthritis, inflammatory bowel diseases, and immune-mediated inflammatory conditions such as psoriasis, and psoriatic arthritis. biosimilars for infliximab, then etanercept and finally adalimumab are approved by European countries for treatment of immune-mediated inflammatory diseases (Baumgart, 2019). There are different factors affecting improvement of patient access to biosimilars. Low cost of biosimilars relative to reference products is an important advantage can improve patient access. Knowledge of physicians, patient understanding about variety of benefits of biosismilars and supporting patients by marketing communications and public relations may encourage the use of these agents. Efficacy, quality and safety of biosimilars may ensure patients make treatment decision (Kim, 2020).